Until recently, CDC had warned that it remained uncertain how effective the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA) and the ACAM2000 vaccine from Emergent BioSolutions (NYSE:EBS) were at guarding against the current monkeypox outbreak. The CDC, however, has begun to release data related to the former vaccine. The agency found unvaccinated patients were approximately 14…
Bavarian Nordic launches Phase 3 clinical study of COVID-19 booster candidate
Bavarian Nordic (OMX:BAVA) has dosed the first subject in a Phase 3 clinical study of the COVID-19 vaccine candidate ABNCoV2. The study will test whether ABNCoV2 is non-inferior to Comirnaty from Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) in terms of neutralizing antibodies it produces against the original strain of SARS-CoV-2. Secondary endpoints in the study will…
EMA emergency task force backs intradermal use of Imvanex/Jynneos monkeypox vaccine
EMA’s Emergency Task Force (ETF) has given national authorities in the EU permission to use the Imvanex vaccine as an intradermal injection while supplies of the vaccine remain limited. In a statement, the ETF described the decision as a “temporary measure.” The FDA recently reached a similar decision but authorized the intradermal use of the Imvanex…
3 critical monkeypox vaccine questions
In the U.S., federal authorities have allowed two vaccines to be used to reduce the risk of monkeypox virus infection. The preferred option is the Jynneos vaccine from Bavarian Nordic (OMX:BAVA), followed by Emergent BioSolutions’ (NYSE:EBS) ACAM2000. While vaccination efforts are ramping up, California, New York and Illinois have declared states of emergency as the…
FDA greenlights 786,000 additional monkeypox vaccine doses
FDA has signed off on a supplement to the biologics license for Bavarian Nordic’s (OTCMKTS:BVNRY) Jynneos vaccine, which is indicated for both monkeypox and smallpox. The move will make an additional 786,000 doses of vaccine available for use in the U.S. The extra doses are available following an FDA expedited inspection and approval of Bavarian…
U.S. purchases more monkeypox vaccine doses from Bavarian Nordic
Bavarian Nordic A/S (OMX:BAVA) has announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has ordered an additional 2.5 million doses of liquid-frozen Jynneos vaccine. FDA first approved Jynneos, a non-replicating smallpox and monkeypox vaccine, in 2019. It continues to be the only FDA-approved vaccine indicated for monkeypox. The company will begin deliveries…
U.S. secures option to purchase millions of monkeypox vaccine doses from Bavarian Nordic
As monkeypox cases are investigated in North America and Europe, Bavarian Nordic A/S (OMX:BAVA) has secured a contract worth potentially $119 million with Biomedical Advanced Research and Development Authority (BARDA) to convert bulk vaccine into freeze-dried doses of Jynneos vaccine. Jynneos was FDA approved for both smallpox and monkeypox in 2019. Smallpox and monkeypox are broadly…